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RecruitingNCT06581978Updated Sep 3, 2024

Early Warning and Intervention Mechanism of Foot Health Risk in Children and Adolescents

An interventional study of Whole-Body Vibration Intervention and Exercise Intervention Group in Flexible Flatfoot, sponsored by Nanfang Hospital, Southern Medical University. Recruiting at 1 site in China. Open to participants aged 6 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-03.

Sponsored by Nanfang Hospital, Southern Medical University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Jan 2024, registered Aug 2024).
  • Started Jan 2024; still recruiting 2 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
6 Years to 18 Years
Sex
All
01

Study summary

This clinical study was a prospective intervention study. The growth and development parameters and kinematic parameters of 120 children were planned to be collected for an observational study, and then the sensors were used to collect long-term gait data for 4 weeks and record the occurrence of foot pain. Children were assigned to the observation group, exercises intervention group, or WBV vertical rhythm intervention group according to their wishes. After 4 weeks of intervention, the dynamic and static foot posture differences between the intervention group and the observation group were analyzed and compared.

Read the detailed description

This clinical study plan to recruit 120 subjects aged 6-18 years to collect the following parameters:

  1. Three-dimensional shape of foot: The three-dimensional shape parameters of foot are obtained by 3D morphometric scanner, which is harmless to human body and has no radiation. The subjects stand barefoot on a 3D morphometric scanner and test their left and right feet respectively.
  2. Static foot posture: foot Posture Index-6, foot X-ray bearing position.
  3. Bone age analysis: Bone age is measured by using the stereotype protected mobile wrist with microradiation amount.
  4. Bone mineral density analysis: calcaneal bone mineral density is measured by musculoskeletal ultrasound.
  5. Genome grouping: Children's saliva is collected for whole genome analysis.
  6. Body fat analysis: Bioresistive method was used to evaluate body fat ratio.
  7. TCM physique assessment: Classification and Identification of TCM physique of Children in Guangdong Region by TCM Physique Scale combined with tongue image analysis (T/GDACM 0112 -- 2022).
  8. Passive optical motion capture system, plantar pressure system and surface EMG system are used to collect kinematic parameters.

A wearable sensor is used to collect gait data for more than 8 hours per day for 4 weeks, and all enrolled children wear the wearable sensor in their daily lives. The obtained data is uploaded to the cloud server through the mobile application, and the data is uploaded through the APP to achieve remote monitoring and daily event recording. When the subject has a foot pain event, it should be reported to the researchers through the APP in time. After determining the foot pain based on the VAS score, the foot pain subjects will be divided into the observation group, the exercise intervention group and the WBV vertical rhythm intervention group according to their willingness.

The children in the observation group followed the doctor's advice to rest and did not participate in sports activities. The children in the intervention group were followed up by the researchers to implement the WBV vertical rhythm or exercise training program. The follow-up time was once a week and the training lasted for 4 weeks. The self-developed APP was used for researchers to remotely monitor and guide children's training movements and track training progress. The device uses a Huawei S-TAG anklet that matches HarmonyOS 2+/Android 6.0+/iOS 9.0+. IP68 (GB/T 4208-2017), waterproof grade 50 meters; Bluetooth: BT 5.0 to transmit data; Running scenario battery life: running 1 hour a day, running 5 days a week, stationary placement when not in use, battery life of 30 days.

  1. WBV vertical rhythm training standard procedure: Enrolled children will be trained at home using vertical rhythm equipment under the guidance of researchers and parental supervision. WBV training lasted for four weeks, five days a week, 15 minutes a day, each movement lasted for 30 seconds, and 30 seconds of rest between groups.
  2. Standard process of TCM exercise training: The enrolled children will be supervised by their parents and follow the teaching of the self-developed APP for exercise training. The Yi Jin Jing training lasts for 4 weeks, 5 days a week, 15 minutes a day, 12 movements in total, each movement is 1 minute, and the rest between groups is 15 seconds. Improvement in static and dynamic foot posture is assessed at the end of the 4-week training period.
02

Conditions studied

  • Flexible Flatfoot

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Keywords

  • Children
  • Flatfoot
  • Traditional Chinese medical exercises training
  • Wearable sensors
  • Whole body vibration
03

In context

Flatfoot

173 studies on the registry are indexed under Flatfoot; 44 are open to participants now.

This study's planned enrollment of 120 is above the median of 40 across 122 interventional studies indexed under Flatfoot.

Browse Flatfoot studies →

Lead sponsor

Nanfang Hospital, Southern Medical University is the lead sponsor of 490 studies on the registry; 214 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. They agreed to participate in the study, and their legal representatives voluntarily signed an form
  2. 6-18 years old typical development of children and adolescents, gender not limited

Exclusion criteria

Exclusion Criteria:

  1. In addition to the flat feet, there are other effects foot posture or spinal congenital malformation of the lower limbs
  2. At the investigator's discretion, he was not considered to be suitable to participate in the study
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Whole-Body Vibration Intervention Group

    Enrolled children will be trained at home using a vertical rhythm device under the guidance of researchers and parental supervision. WBV training lasted for four weeks, five days a week, 15 minutes a day, each movement lasted for 30 seconds, and 30 seconds of rest between groups.

    Procedure: Exercise Intervention Group

  • No intervention
    Control Group

    Children were instructed to rest and not participate in physical activity

  • Experimental
    Traditional Chinese medical exercises training Intervention Group

    The enrolled children will be supervised by their parents and follow the teaching of the self-developed APP for Yi Jin Jing exercises. The training lasts for 4 weeks, 5 days a week, 15 minutes a day, 12 movements in total, each movement is 1 minute, and the rest between groups is 15 seconds.

    Procedure: Whole-Body Vibration Intervention

Interventions

  • ProcedureWhole-Body Vibration Intervention

    Whole-Body Vibration Intervention

  • ProcedureExercise Intervention Group

    Traditional Chinese medical exercises training

06

What researchers measure

Primary outcomes

  1. Static foot posture

    Static foot posture is evaluated using 3D morphometric scanner, X-ray, and Foot Posture Index-6

    Time frame: Baseline , pre-intervention and immediately after the intervention

  2. Motional foot posture

    Motional foot posture is evaluated using Passive optical motion capture, and wearable sensors

    Time frame: Baseline , pre-intervention and immediately after the intervention

Secondary outcomes

  1. Foot pain events

    Visual Analogue Scale (VAS) is used to evaluate foot pain, which asks patients to rate their pain level on a scale of 0 to 10 (0 = no pain; 10 = "worst pain ever"). On the VAS scale, patients draw a hash mark representing their pain level on an unmarked 10-cm line, with the left side marked as "no pain" and the right side marked as "unbearable pain".

    Time frame: Baseline , pre-intervention

  2. Bone maturity

    Bone age taken by dual energy X ray bone age instrument, the equipment radiation is extremely low, the equivalent of flying two minutes, or about 20 minutes of walking in the sunshine, won't cause harm to human body. Bone mineral density (BMD) was measured by ultrasound bone densitometer, which can be used to measure the BMD of calcaneus in children without radiation and trauma.

    Time frame: Baseline , pre-intervention

07

Study locations

1 of 1 sites recruiting
  • Nanfang Hospital, Southern Medical University
    Guangzhou, Guangdong 510515, China
    Recruiting
    • Chao Chen, PhD · Contactpizzachan@163.com · 13580348819
    • Chao Chen, PhD · Principal investigator
    • Ziyu Feng, MA.Sc · Sub investigator
    • Jingyi She, BS · Sub investigator
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2024 (actual). Primary completion is estimated for Dec 2027, 47 months after the start.

Of 89 non-industry interventional studies with no phase under Flatfoot, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 15. This study's planned 47 months is above that.

Counting every sponsor, half of 89 studies reached it within 7 months; a quarter within 2 and three quarters within 15.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 25, 2024
First posted
Sep 3, 2024
StartActual
Jan 1, 2024
Primary completionEst.
Dec 31, 2027
CompletionEst.
Dec 31, 2027
Last update
Sep 3, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06581978
Responsible party
Sponsor
First posted
Sep 3, 2024
Start date
Jan 1, 2024
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Sep 3, 2024

Study contacts

Chao Chen, PhD
Contact
pizzachan@163.com
13580348819 ext. 020-61648254

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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